Adherus ET AutoSpray Dural Sealant, NUS-109
FDA premarket approval P130014/S015 · decided 2022-03-16
Approval details
- PMA number
- P130014
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adherus ET AutoSpray Dural Sealant, NUS-109
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2022-03-04
- Decision date
- 2022-03-16
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Steris Applied Technologies dba Synergy Health AST, LLC facility located in Saxonburg, Pennsylvania (Steris AST Saxonburg) to use a functionally equivalent electron accelerator to sterilize Adherus AutoSpray ET Dural Sealants
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